CLASS II ONGOING Device recall · Reported 30 Sep 2026 · FDA Enforcement Report

Extended Polyaxial Head, Attached Gimbal recalled

Seaspine Orthopedics is recalling Extended Polyaxial Head, Attached Gimbal, distributed nationwide in the US. The recall was initiated on 19 Aug 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI 10889981257248; Affected Lots: TE145060D, TE170356F, TE170556F, TE165793F, TE145059E, TE161254F, TE142282D.

Quantity recalled270 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-3226-2026
FDA event ID: 99691
Recalling firm: Seaspine Orthopedics, Carlsbad, CA
Classification: Class II
Status: Ongoing
Recall initiated: 19 Aug 2026
FDA classified: 18 Sep 2026
Reported: 30 Sep 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Spinal Implants

Timeline

19 Aug 2026	Recall initiated by company
18 Sep 2026	Classified by FDA	+30 days
30 Sep 2026	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The proximal thread depth of the spinal device is out of design specification.

Product as listed by the FDA

SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm REF: MD1-300010-12

Where it was distributed

US Nationwide distribution in the states of Alabama, California, Colorado, Connecticut, Florida, Georgia, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, Nevada, New York, Oklahoma, Oregon, Tennessee, Texas, and Virginia.

Nationwide Alabama California Colorado Connecticut Florida Georgia Massachusetts Michigan Minnesota Missouri North Carolina Nevada New York Oklahoma Oregon Tennessee Texas Virginia

Questions about this recall

Why was it recalled?

The proximal thread depth of the spinal device is out of design specification.

Which lots are affected?

UDI-DI 10889981257248; Affected Lots: TE145060D, TE170356F, TE170556F, TE165793F, TE145059E, TE161254F, TE142282D.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 6 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Seaspine Orthopedics

All 11

Reported	Class	Recall	Company	Reason	Where
29 Jul 2026Device	CLASS II	SeaSpine Polyaxial Head recalled by Seaspine Orthopedics	Seaspine Orthopedics	Other	Nationwide
24 Dec 2025Device	CLASS II	Orthofix NorthStar OCT Navigation Surgical Technique Guide recalled	Seaspine Orthopedics	Other	24 states
17 Sep 2025Device	CLASS II	Reef TA Inserter recalled by Seaspine Orthopedics	Seaspine Orthopedics	Other	Nationwide
1 Jan 2025Device	CLASS II	Daytona Small Stature Ti Locking Cap, Small Stature, T25 recalled	Seaspine Orthopedics	Device Malfunction	Nationwide
1 Jan 2025Device	CLASS II	Daytona Small Stature CoCr LockingCap, Small Stature, T25, BT recalled	Seaspine Orthopedics	Device Malfunction	Nationwide

Other Spinal Implants recalls

All 1,159

Reported	Class	Recall	Company	Reason	Where
30 Sep 2026Device	CLASS II	Medline Convenience Kits: Anterior Spine Pack recalled	Medline Industries	Other	Nationwide
9 Sep 2026Device	CLASS II	Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled	Avid Medical	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Halyard medical convenience kits labeled as: ENT recalled	Avid Medical	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Halyard medical convenience kits labeled as: A-P PACK recalled	Avid Medical	Sterility	Nationwide
2 Sep 2026Device	CLASS II	Medline medical convenience kits, labeled as recalled	Medline Industries	Other	Nationwide